Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
An important feature of neurosurgical anesthesia is early postoperative recovery of consciousness with minimal residual sedation. This is a key factor to enable early neurological assessment and early discovery of postoperative complications.
The goal of this single centre clinical trial is to compare propofol/remifentanil anesthesia delivered by manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI) for intracranial tumor resection via craniotomy. Anesthetic depth will be assessed by a simplified processed EEG (pEEG).
The main question is time spent within recommended pEEG- levels from anesthesia induction until end of surgery.
Secondary questions are:
* mean pEEG-level, time from end of surgery to consiousness, * peroperative propofol/remifentanil consumption * postoperative degree of sleepiness * awareness assessment
Participants are adults having have planned surgery for open resection of a brain tumor and will receive general anesthesia with propofol and remifentanil randomized to mTIVA or TCI. pEEG vill be blinded.
* Participants will be asked to grade postoperative sleepiness using a specific scale * Follow up regarding awareness will be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective craniotomy for tumor resection
Adult patient
Consent to participation
Disqualifiers
Cognitive impact affecting infrmed consent
brain tumor planned for biopsy without resection Tumor localisation not permitting placement of pEEG electrodes.
Trial design
Design model
Parallel
Treatments tested in this trial
depth of anesthesia
DeviceTime spent within recommended pEEG-levels
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: TIVAActive comparator 1 intervention
Group B: TCIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Amount of time during anestehsia and surgery within recommended levels of processed EEG (pEEG)
Prior to induction processed EEG (pEEG) will be applied. The pEEG result will not be available to anesthetic personel during surgery. Patients will be anestetised using TIVA or TCI (propofol/remifentanil). Primary endpoint is time within recommended levesl of pEEG.
Time frame
During anesthesiaSponsors and contacts
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Source ClinicalTrials.gov